EMA – Publication of Real-world evidence framework to support EU regulatory decision-making: 2nd report on the experience gained with regulator-led studies from February 2023 to February 2024

The EMA published its 2^nd report on the Real-world evidence framework to support EU regulatory decision-making for the period between February 2023 and February 2024.

This report builds on the experience previously acquired during the period from September 2021 to February 2023 in conducting regulatory-led studies using real-world data (RWD) to support EU regulatory decisions (see previous report here). It covers the period from 8 February 2023 to 7 February 2024, which corresponds to year 2 of DARWIN EU and provides a review of the progress made in delivering on the vision of EU regulators to enable the use of RWE and establish its value for regulatory decision- making by 2025 (Arlett et al., 2022). This is in line with the European Medicines Regulatory Network (EMRN) strategy to 2025 as well as the Agency’s Regulatory Science Strategy to 2025. The European Medicines Agency (EMA) alongside the EMRN is working towards the establishment of a framework to enable better integration of real-world data (RWD)/real-world evidence (RWE) alongside the gold standard of randomised controlled trials into regulatory decisions on the development, authorisation and supervision of medicines. The report follows the priority recommendations of the Big Data Task Force as implemented through the Big Data Steering Group and the fourth multiannual work plan (2023-2025)

More information on the Real-world evidence dedicated page on the EMA Website.